Tip assemblies, systems, and methods for fracturing a frame of a deployed prosthesis

ABSTRACT

A system for fracturing a frame of a deployed prosthesis with ultrasonic vibration includes a shaft, a tip assembly, an ultrasonic electric generator, and an ultrasonic transducer. The shaft includes a proximal portion and a distal portion. The tip assembly is coupled to the distal portion of the shaft. The tip assembly includes a cutting edge. The ultrasonic transducer is electrically coupled to the ultrasonic generator. Ultrasonic vibration generated by the ultrasonic transducer is translated to the tip assembly. The cutting edge of the tip assembly is configured to focus the vibration of the tip assembly onto a frame of a deployed prosthesis to fracture the frame of the prosthesis. The ultrasonic transducer may be coupled to the proximal portion or the distal portion of the shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) of U.S.Provisional Application No. 62/666,480, filed May 3, 2018, the contentsof which are incorporated by reference herein in their entirety.

FIELD OF THE INVENTION

The present invention relates to systems and methods for fracturing aframe of a deployed stented prosthesis. More particularly, the presentinvention relates to a system with a tip assembly for fracturing a frameof a deployed stented heart valve prosthesis with ultrasonic energy.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atria and right ventricle which supplies thepulmonary circulation, and the left atria and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To ensure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atria and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The leaflets move apart from each other to open and allowblood to flow downstream of the valve, and coapt to close and preventbackflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber from occurring at the proper flow rate and may cause the heartto work harder to pump the blood through the diseased valve. Valvularinsufficiency or regurgitation occurs when the valve does not closecompletely, allowing blood to flow backwards, thereby causing the heartto be less efficient. A diseased or damaged valve, which can becongenital, age-related, drug-induced, or in some instances, caused byinfection, can result in an enlarged, thickened heart that loseselasticity and efficiency. Some symptoms of heart valve diseases caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Symptoms can often be severeenough to be debilitating and/or life threatening.

Stented heart valve prostheses have been developed for repair andreplacement of diseased and/or damaged heart valves, and heart valvereplacement has become a routine surgical procedure for patientssuffering from valve dysfunctions. Traditional open surgery inflictssignificant patient trauma and discomfort, requires extensiverecuperation times, and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiacvalve replacements using minimally invasive techniques. In thesemethods, laparoscopic instruments are employed to make small openingsthrough the patient's ribs to provide access to the heart. Whileconsiderable effort has been devoted to such techniques, widespreadacceptance has been limited by the clinician's ability to access onlycertain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheterdelivery and implantation of replacement cardiac valves to solve theproblems presented by traditional open surgery and minimally invasivesurgical methods. In such methods, a stented heart valve prosthesis,also known generally as a valve prosthesis, is compacted for delivery ina catheter and then advanced, for example through an opening in thefemoral artery, through the inferior vena cava, through the interatrialseptum, where the valve prosthesis is then deployed in the annulus ofthe native heart valve.

Various types and configurations of valve prostheses are available forpercutaneous valve replacement procedures. In general, stented heartvalve prostheses designs attempt to replicate the function of the heartvalve being replaced and thus will include valve leaflet-likestructures. Valve prostheses are generally formed by attaching abioprosthetic valve to a frame made of a wire or a network of wires.Such a valve prosthesis can be collapsed radially to introduce the valveprosthesis into the body of the patient percutaneously through acatheter. The valve prosthesis may be deployed by radially expanding itonce positioned at the desired deployment site.

A deployed valve prosthesis in a patient may need to be replaced forreasons including the valve prosthesis reaching its useful service life,restenosis and/or calcification of the deployed valve prosthesis, orphysical growth of the patient such that the deployed valve prosthesisis no longer sufficient. A deployed valve prosthesis may bepercutaneously replaced with a new valve prosthesis in what is referredto as a valve-in-valve replacement procedure, wherein the new valveprosthesis is deployed within the older, previously deployed valveprosthesis. However, expanding the deployed valve prosthesis with aballoon or a new valve prosthesis within a deployed stenotic and/orcalcified valve prosthesis may not result in a large enough orifice oreffective diameter to accommodate the new valve prosthesis. Morespecifically, the balloon or new self-expanding valve prosthesis may nothave sufficient outward radial force to expand the old, deployedstenotic and/or calcified valve prosthesis enough to provide sufficientblood flow through the newly deployed valve prosthesis. Accordingly,there is a need for equipment and methods to safely expand a deployedvalve prosthesis prior to valve-in-valve replacement.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof further relate to a system for fracturing a frame ofa deployed prosthesis, e.g., a valve prosthesis. The system includes ashaft, a tip assembly, an ultrasonic electric generator, and anultrasonic transducer. The shaft includes a proximal and a distalportion. The tip assembly is coupled to the distal portion of the shaftand includes a cutting edge. The ultrasonic transducer is electricallycoupled to the ultrasonic electric generator. Ultrasonic vibrationgenerated by the ultrasonic transducer is translated to the tipassembly. The cutting edge of the tip assembly is configured to focusthe ultrasonic vibration onto a frame of a deployed valve prosthesis tofracture the frame.

Embodiments hereof further relate to a tip assembly for fracturing aframe of a valve prosthesis with ultrasonic vibration. The tip assemblyincludes at least one segment and a cutting edge coupled to the at leastone segment. The cutting edge is configured to focus ultrasonicvibration of the tip assembly.

Embodiments hereof also relate to a method of fracturing a frame of adeployed valve prosthesis. The system is advanced to the site of adeployed valve prosthesis. The system includes a shaft, a tip assembly,an ultrasonic electric generator, and an ultrasonic transducer. The tipassembly of the system is positioned at a connection point to befractured of a frame of the deployed valve prosthesis. A cutting edge ofthe tip assembly is placed in contact with the desired connection pointto be fractured. A longitudinal force, either in a distal or a proximaldirection, is applied to the shaft to hold the cutting edge of the tipassembly in contact with the desired connection point. The ultrasonicgenerator and the ultrasonic transducer are activated. When theconnection point of the frame has fractured, the ultrasonic generatorand the ultrasonic transducer are deactivated.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 depicts a schematic illustration of an exemplary valve prosthesisfor use with embodiments hereof.

FIG. 2 depicts a perspective illustration of the valve prosthesis ofFIG. 1 .

FIG. 3 depicts a side view illustration of a system according to anembodiment hereof, wherein the system includes an ultrasonic transducerat a proximal portion of a shaft of the system and a tip according to anembodiment hereof.

FIG. 4 depicts a sectional cut-away illustration of a heart and thesystem of FIG. 3 positioned at a desired connection point to befractured of a frame of a deployed valve prosthesis.

FIG. 5A depicts a close-up perspective illustration of a tip assembly ofthe system of FIG. 4 , wherein the tip assembly is adjacent to and incontact with the desired connection point of the frame of the deployedvalve prosthesis.

FIG. 5B depicts a close-up perspective illustration of the valveprosthesis of FIG. 5A, wherein the connection point has been fracturedand the tip assembly of the system has been omitted for clarity.

FIG. 5C depicts the valve prosthesis of FIG. 4 , wherein a plurality ofconnection points have been fractured to form a “zipper down” opening inthe frame of the valve prosthesis.

FIG. 6 depicts a side view illustration of a tip assembly according toanother embodiment hereof.

FIG. 7 depicts a sectional cut-away illustration of a heart and the tipassembly of FIG. 6 positioned at a desired connection point to befractured of a frame of a deployed valve prosthesis.

FIG. 8 depicts a close-up perspective illustration of the tip assemblyof FIG. 6 , wherein the tip assembly is adjacent to and in contact withthe desired connection point of the frame of the deployed valveprosthesis.

FIG. 9 depicts a side view illustration of a tip assembly according toanother embodiment hereof.

FIG. 10 depicts a sectional cut-away illustration of a heart and the tipassembly of FIG. 9 positioned at a desired connection point to befractured of a frame of a deployed valve prosthesis.

FIG. 11 depicts a close-up perspective illustration of the tip assemblyof FIG. 9 , wherein the tip assembly is adjacent to and in contact withthe desired connection point of the frame of the valve prosthesis.

FIG. 12 depicts a side view illustration of a system according toanother embodiment hereof, wherein the system includes an ultrasonictransducer disposed at a distal portion of a shaft of the system.

FIG. 13 depicts a cross-sectional illustration of the shaft of thesystem, taken along the line 13-13 of FIG. 12 .

FIG. 14 depicts a side view illustration of a system according to yetanother embodiment hereof, wherein the system includes an ultrasonictransducer disposed at a tip assembly of the system.

FIG. 15A depicts a side view illustration of a system according toanother embodiment hereof, wherein the system includes a catheter shaft.

FIG. 15B depicts a cross-sectional illustration of the shaft of thesystem, taken along the line 15B-15B of FIG. 15A.

FIG. 16 is a sectional cut-away illustration of an aorta of a heartillustrating a method step of using the system of FIG. 3 to fracture aframe of a deployed aortic valve prosthesis in accordance with anembodiment hereof, wherein a tip assembly is positioned adjacent theframe of the deployed valve prosthesis.

FIG. 17 is a sectional cutaway illustration of the heart illustrating amethod step of using the system of FIG. 3 to fracture the frame of thedeployed valve prosthesis, wherein a sharpened edge of the tip assemblyis adjacent a desired connection point to be fractured.

FIG. 18 is a close-up perspective illustration of tip assemblyillustrating a method step of using the system of FIG. 3 to fracture theframe of the deployed valve prosthesis, wherein the sharpened edge ofthe tip assembly is in contact with the desired connection point to befractured.

FIG. 19 is a sectional cutaway illustration of the heart illustrating amethod step of using the system of FIG. 3 to fracture the frame of thedeployed valve prosthesis, wherein the sharpened edge has fractured orseparated the desired connection point.

FIG. 20 is a sectional cutaway illustration of the heart illustrating amethod step of using the system of FIG. 3 to fracture the frame of thedeployed valve prosthesis, wherein the system has been removed to leavethe fractured valve prosthesis.

FIG. 21 depicts a side view illustration of a system according to anembodiment hereof, wherein a tip assembly of the system includes asafety bumper and a flat, rounded tip according to an embodiment hereof.

FIG. 22 depicts a close-up perspective illustration of the tip assemblyof the system of FIG. 21 , wherein the tip assembly is adjacent to andin contact with the desired connection point of the frame of thedeployed valve prosthesis.

FIG. 23 depicts a side view illustration of a system according to anembodiment hereof, wherein a tip assembly of the system includes asafety bumper and a flat, rectangular tip according to an embodimenthereof.

FIG. 24 depicts a close-up perspective illustration of the tip assemblyof the system of FIG. 23 , wherein the tip assembly is adjacent to andin contact with the desired connection point of the frame of thedeployed valve prosthesis.

FIG. 25 depicts a side view illustration of a system according to anembodiment hereof, wherein a tip assembly of the system is in acollapsed configuration according to an embodiment hereof.

FIG. 26 depicts a top view illustration of the tip assembly of thesystem of FIG. 25 , wherein the tip assembly is in the collapsedconfiguration.

FIG. 27 depicts a cross-sectional illustration of a shaft of the systemtaken along the line 27-27 of FIG. 26 .

FIG. 28 depicts a side view illustration of the system of FIG. 25 ,wherein a tip assembly of the system is in an expanded configurationaccording to an embodiment hereof.

FIG. 29 depicts an exploded illustration of the tip assembly of FIG. 25.

FIG. 30A depicts a side view illustration of a system according to anembodiment hereof, wherein the system includes a first tip assembly anda second tip assembly according to an embodiment hereof.

FIG. 30B depicts a cross-sectional illustration of the system takenalong the line 30B-30B of FIG. 30A.

FIG. 31 depicts a close-up perspective illustration of a distal portionof the system of FIG. 30A.

FIG. 32 depicts a close-up perspective illustration of the tip assemblyof the system of FIG. 30A, wherein each tip assembly is adjacent to andin contact with the desired connection point of the frame of thedeployed valve prosthesis.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to a shaftor system are with respect to a position or direction relative to thetreating clinician. Thus, “distal” and “distally” refer to positionsdistant from, or in a direction away from the treating clinician, andthe terms “proximal” and “proximally” refer to positions near, or in adirection toward the clinician. The terms “distal” and “proximal”, whenused in the following description to refer to a device to be implantedinto a vessel, such as a heart valve prosthesis, are used with referenceto the direction of blood flow from the heart. Thus, “distal” and“distally” refer to positions in a downstream direction with respect tothe direction of blood flow, and the terms “proximal” and “proximally”refer to positions in an upstream direction with respect to thedirection of blood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of the invention is in the contextof a system for fracturing a frame of a deployed heart valve prosthesis,the invention may also be used for fracturing a frame of a non-valveprosthesis, for example, in other body passageways where it is deemeduseful. Furthermore, there is no intention to be bound by any expressedor implied theory presented in the preceding technical field,background, brief summary or the following detailed description.

The present invention in various embodiments relates to a system with atip assembly for fracturing or breaking a portion of a frame of adeployed valve prosthesis at a site of a native valve utilizingultrasonic vibration. “Fracturing”, “fractured”, or “fracture” as usedherein is meant to convey that a structure is separated, broken,divided, or moved apart or caused to be separated, broken, divided ormoved apart. The frame to be fractured may be a frame or stent of aheart valve prosthesis 100, hereafter referred to as the valveprosthesis 100 for sake of brevity, as shown in the embodiment of FIGS.1 and 2 . The valve prosthesis 100 includes a frame 102 supporting aprosthetic valve 104. For example, the valve prosthesis 100 useful withthe present disclosure can be a prosthesis sold under the trade nameEvolut R® available from Medtronic CoreValve, LLC and as described inU.S. Pat. No. 8,226,710 to Nguyen et al., which is incorporated byreference herein in its entirety. The valve prosthesis 100 has aradially expanded configuration when deployed. The valve prosthesis 100is illustrated herein in order to facilitate description of systems andtip assemblies for fracturing a deployed frame of a valve prosthesiswith ultrasonic vibration prior to a procedure such as a valve-in-valvereplacement, as described below according to embodiments hereof. Whilethe valve prosthesis 100 illustrated herein is of a specificconstruction and structure, it is not meant to be limiting, andalternate valve prostheses can be used with the methods and devicesdescribed herein. The valve prosthesis 100 is merely exemplary. It isunderstood that any number of alternate valve prostheses can be usedwith the methods and devices described herein. Further, while the valveprosthesis 100 is described herein for used as an aortic valveprosthesis, this is only exemplary, and the valve prosthesis may assumevarious configurations for use at other locations within the heart andthe body.

The frame 102, as shown in FIG. 1 , also referred to as a stent orsupport structure, can have, for example, a flared, funnel-like orhyperboloid shape. Accordingly, the frame 102 defines a lumen 106extending from an inflow or proximal end 108 to an outflow or distal end110. The frame 102 includes a radially collapsed configuration fordelivery and a radially expanded configuration when deployed. The frame102 is a structural component of the valve prosthesis 100, and thus,when the frame 102 is in the radially expanded configuration, the valveprosthesis 100 is in the radially expanded configuration. The frame 102is configured to engage tissue at the annulus of the native heart valvewhen the frame is in the radially expanded configuration. The frame 102is further configured to provide a secure mounting surface for theprosthetic valve 104. The frame 102 includes a plurality of cells 112formed by a plurality of struts 114 joined by bent segments or crowns116. The cells 112 may have sizes that vary along the length of thestent-like frame 102. In the embodiment shown in FIG. 1 , selectedlongitudinally adjacent crowns 116 may be joined by, for example, at aconnection point 118. However, the invention is not limited to thepattern shown in FIG. 1 . When configured as a replacement for an aorticvalve, the inflow end 108 extends into and anchors within the aorticannulus of a patient's left ventricle and the outflow end 110 ispositioned in the patient's ascending aorta. Embodiments of the frame102 may include structural components such as, but not limited to theplurality of struts 114 arranged relative to each other to provide adesired compressibility and strength. As described herein, the frame 102is self-expanding from the radially collapsed configuration to theradially expanded configuration. Alternatively, the frame 102 may beballoon expandable or mechanically expandable. The frame 102 may be madefrom materials such, but not limited to nickel-titanium alloys (e.g.,NITINOL) and other super-elastic materials. “Self-expanding” as usedherein means that a structure has a mechanical memory to return to theradially expanded configuration. Mechanical memory may be imparted onthe structure that forms the stent-like frame 102 using techniquesunderstood in the art.

As previously described herein, the valve prosthesis 100 includes theprosthetic valve 104 within the interior of the frame 102. Theprosthetic valve 104 may further include a skirt 120 affixed to theframe 102. The prosthetic valve 104 is configured as a one-way valve toallow blood flow in one direction and thereby regulate blood flow therethrough. The prosthetic valve 104 is capable of blocking flow in onedirection to regulate flow via valve leaflets. More particularly, whenthe valve prosthesis 100 is configured for placement within a nativeheart valve having three (3) leaflets such as the aortic valve, as shownin FIGS. 1 and 2 , the prosthetic valve 104 may include three (3) valveleaflets 122, 124, 126 to form a tricuspid replacement valve that closeswith pressure on the outflow and opens with pressure on the inflow. Inother embodiments in accordance herewith, the prosthetic valve 104 maybe a bicuspid replacement valve or may be a single leaflet replacementvalve. The valve leaflets are sutured or otherwise securely andsealingly attached to an inner circumference of the frame 102.

The valve leaflets 122, 124, 126 of the prosthetic valve 104 may be madeof natural pericardial material obtained from, for example, heartvalves, aortic roots, aortic walls, aortic leaflets, pericardial tissue,bypass grafts, blood vessels, intestinal submucosal tissue, umbilicaltissue and the like from humans or animals, such as tissue from bovine,equine or porcine origins. Alternatively, the valve leaflets of theprosthetic valve 104 may be made of synthetic materials suitable for useas heart valve prosthesis leaflets in embodiments hereof including, butare not limited to polyester, polyurethane, cloth materials, nylonblends, and polymeric materials.

A system 301 for fracturing a frame of a deployed valve prosthesis, suchas the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to an embodiment hereof isshown in FIGS. 3-5A. The system 301 includes a shaft 303, a tip assembly305, an ultrasonic electric generator 307, and an ultrasonic transducer309. The system 301 is configured to fracture at least one desiredconnection point 118 of the deployed valve prosthesis 100 withultrasonic vibration. For example, ultrasonic fracturing of the frame102 may be required prior to the deployment of a new replacement valveprosthesis in a valve-in-valve replacement procedure. In anotherexample, ultrasonic fracturing of the frame 102 may be required toexpose access to a coronary sinus for a coronary procedure. Morespecifically, the system 301 is configured to safely fracture the frame102 of the deployed valve prosthesis 100 without damaging thesurrounding tissue.

The shaft 303 is a flexible shaft with a generally tubular shape andincludes a proximal portion 311 and a distal portion 313. “Generally” asused herein, particularly with respect to the terms “tubular”,“circular, and “traverse” means within normal manufacturing tolerances.In the embodiment of FIGS. 3-5A, the ultrasonic transducer 309 iscoupled to the proximal portion 311 and the tip assembly 305 is coupledto the distal portion 313 as described below. The shaft 303 isconfigured to translate vibration or movement from the proximal portion311 to the distal portion 313. More specifically, the shaft 303 isconfigured to translate ultrasonic vibration generated by the ultrasonictransducer 309 to the tip assembly 305. “Translated” as used hereinmeans that an ultrasonic vibration is transferred, conveyed, transmittedor otherwise passed from one component, for example the shaft 303 toanother component, for example the tip assembly 305. Although the shaft303 is described herein as a single component, this is not meant tolimit the design, and the shaft 303 may include components such as, butnot limited to a proximal shaft, a distal shaft, a handle, or othercomponents suitable for the purposes described herein. The shaft 303 maybe constructed of materials such as, but not limited to stainless steel,titanium, tantalum, tungsten, or other materials suitable for thepurposes of the present disclosure.

The shaft 303 is configured to be disposed with a portion of the shaft303 extending outside of a patient, i.e., the proximal portion 311, anda portion of the shaft 303 positioned in situ within a body lumen orvessel, i.e., the distal portion 313. The shaft 303 is furtherconfigured to deliver and position the tip assembly 305 of the system301 at the site of the deployed valve prosthesis 100, as describedbelow. Accordingly, the shaft 303 and the tip assembly 305 are eachsized and configured to be advanced through a vasculature in a minimallyinvasive manner.

The tip assembly 305 according to an embodiment hereof for fracturing aframe of a deployed valve prosthesis, such as the valve prosthesis 100previously described, is shown in FIGS. 3-5A. The tip assembly 305includes a sharpened edge 315, a first segment 317, a second segment319, and a third segment 321. A proximal portion 323 of the tip assembly305 is coupled to the distal portion 313 of the shaft 303. The tipassembly 305 is configured to translate ultrasonic vibration of the tipassembly 305 onto the frame 102 of the deployed valve prosthesis 100 tofracture the frame 102 of the deployed valve prosthesis 100, asdescribed below. In the embodiment of FIGS. 3-5A, each of the segments317, 319, and 321 of the tip assembly 305 includes a generally tubularshape with a generally circular cross-section. The tip assembly 305 maybe constructed of materials such as, but not limited to stainless steelor other materials suitable for the purposes of the present disclosure.The tip assembly 305 may be coupled to the shaft 303, for example, andnot by way of limitation by adhesives, welding, clamping, or othercoupling methods as appropriate. While the tip assembly 305 is showncoupled to the shaft 303 in a particular coupling configuration, this isby way of example and not limitation, and it will be understood thatother coupling configurations may be utilized. For example, and not byway of limitation, a proximal end of the tip assembly 305 may be coupledto a distal end of the shaft 303. Further, while the first, second, andthird segments 317, 319, and 321 of the tip assembly 305 have each beendescribed with a generally tubular shape and a generally circularcross-section, this is by way of example and not limitation. The first,second, and third segments 317, 319, and 321 may each have alternativeshapes including, but not limited to shapes with an oblongcross-section, a rectangular cross-section, or any other suitable shape.

As best shown in FIG. 3 , the first segment 317 includes a firstlongitudinal axis LA1. The second segment 319 of the tip assembly 305extends radially outward from, or generally transverse to the firstsegment 317. The third segment 321 extends distally from the secondsegment 319 such that the third segment 321 is generally parallel to andradially outward from the first longitudinal axis LA1. Stated anotherway, the third segment 321 is generally parallel to and radially spacedapart from the first segment 317 and the first longitudinal axis LA1. Inthe embodiment of FIGS. 3-5A, the third segment 321 includes a conicalportion 325 and a rounded or atraumatic tip 327 at a distal portionthereof. The third segment 321 is configured such that the third segment321 will not damage tissue during delivery of the tip assembly 305 tothe deployed valve prosthesis 100 or during fracturing of the frame 102,as described below. While the tip assembly 305, and more precisely thefirst segment 317, the second segment 319, and the third segment 321have been described herein as a single component, this is not meant tolimit the design and the first segment 317, the second segment 319, andthe third segment 321 may be separate components coupled together bymethods such as but not limited adhesives, welding, or other couplingmethods as appropriate. Although the first segment 317, the secondsegment 319, and the third segment 321 are each described in FIGS. 3-5Awith a generally circular cross-section, this is by way of example andnot limitation. It will be understood that other cross-sectional shapesmay be utilized for each segment of the tip assembly 305 including, butnot limited to an elliptical shape. Moreover, while the embodiment ofFIGS. 3-5A show the third segment 321 with a conical portion 325, thistoo is by way of example and not limitation and other shapes of thethird segment 321 may be utilized including a cylindrical shape, or anyother shape suitable for the purposes described herein.

In the embodiment of FIGS. 3-5A, the sharpened edge 315 is disposed on adistal facing surface 329 of the tip assembly 305. The sharpened edge315 is configured to focus or concentrate ultrasonic vibration or motionof the tip assembly 305 along the first longitudinal axis LA1 onto thedesired connection point 118 of the frame 102 of the deployed valveprosthesis 100 to fracture the frame 102 at the desired connection point118, as described below. The sharpened edge 315 may be formed by methodssuch as, but not limited to laser ablation, mechanical sharpening,chemical etching, or any other method suitable for the purposesdescribed herein.

Tip assembly 305, as well as other embodiments of tip assembliesdescribed herein, include the sharpened edge 315 configured to focus orconcentrate ultrasonic vibration or motion onto a desired connectionpoint of the frame of the deployed valve prosthesis to fracture theframe at the desired connection point. However, a blunt or flat edge maybe utilized rather than a sharpened edge. The ultrasonic vibration ormotion is less focused or targeted onto a desired connection point ofthe frame of the deployed valve prosthesis with a blunt or flat edge,but the blunt or flat edge poses less of a risk of injury to thesurrounding anatomy during treatment. As such, as used herein, a“cutting edge” is intended to cover both sharpened edges describedherein as well as blunt edges that are suitable for fracturing the frameof a deployed valve prosthesis at a desired connection point.

In the embodiment of FIGS. 3-5A, the ultrasonic electric generator 307is disposed external of the shaft 303 and the ultrasonic transducer 309is disposed at and coupled to the proximal portion 311 of the shaft 303.The ultrasonic electric generator 307 is electrically coupled to theultrasonic transducer 309 by a connection 333. The connection 333 may beany electrical connection capable of carrying an ultrasonic electricsignal generated by the ultrasonic electric generator 307 to theultrasonic transducer 309. The ultrasonic electrical generator 307creates an electrical signal that is, for example, greater than or equalto 20 kHz. The electric signal is transmitted through the connection 333to the ultrasonic transducer 309, which converts the electrical signalto physical motion in the form of ultrasonic mechanical vibration. Theultrasonic vibration is then translated to the coupled proximal portion311 of the shaft 303. More precisely, the ultrasonic vibration generatedby the ultrasonic transducer 309 is translated to the tip assembly 305.The power and frequency of the ultrasonic vibration may be selectedbased upon the application requirements of the procedure to beperformed. In a non-limiting example, the ultrasonic electric generator307 and the ultrasonic transducer 309 may each have a frequency of 20kHz, a power rating of 50 watts, and longitudinally move the coupledshaft 303 and the tip assembly 305 between 5 and 10 microns along thefirst longitudinal axis LA1. The ultrasonic transducer 309 may becoupled to the shaft 303 for example, and not by way of limitation byadhesives, welding, clamping, or other coupling methods as appropriate.While the ultrasonic electric generator 307 is shown disposed externalof the shaft 303, this is by way of example and not limitation, and theultrasonic electric generator 307 may be disposed at other locations ofthe system 301 such as, but not limited to the shaft 303, or any othersuitable location. Further, while the ultrasonic transducer 309 is showndisposed at a specific location within the shaft 303, this too is by wayof example and not limitation. It will be understood that the ultrasonictransducer 309 may be disposed at a variety of locations, including, butnot limited to a location within the shaft 303, on an outer surface ofthe shaft 303, at the proximal portion 311 of the shaft 303, at thedistal portion 313 of the shaft 303, or at any other suitable location.

With reference to FIGS. 3-5C, the interaction of the various componentsof the system 301 will now be described to fracture a connection point,such as the connection point 118 of the frame 102 of the deployed valveprosthesis 100, as shown in FIGS. 4 and 5A-5C. With the components ofthe system 301 assembled and configured as described above, the system301 is advanced to the site of the deployed valve prosthesis 100, whichin the example of FIGS. 4 and 5A-5C is deployed within a native aorticvalve AV. The third segment 321 of the tip assembly 305 is brought intoapposition with the desired connection point 118 to be fractured.

The tip assembly 305 is manipulated to position the sharpened edge 315(obscured from view in FIG. 4 but visible in FIG. 5A) of the tipassembly 305 in contact with the connection point 118 to be fractured.In the embodiment of FIGS. 3-5A, this includes manipulating the tipassembly 305 radially outward such that the third segment 321 passesthrough one cell 112 of the frame 102 that is adjacent to an outflowfacing surface 128 of the desired connection point 118 to be fractured.The atraumatic tip 327 of the third segment 321 prevents damage to theadjacent tissue as the third segment 321 is manipulated radially outwardand the sharpened edge 315 is placed adjacent the desired connectionpoint 118.

When the sharpened edge 315 is positioned adjacent to the outflow facingsurface 128 of the desired connection point 118 to be fractured asdescribed above, the system 301 is distally advanced to place thesharpened edge 315 in contact with the outflow facing surface 128 of theconnection point 118 to be fractured, as best shown in FIG. 5A. It willbe understood that only a portion of the frame 102 is illustrated inFIG. 5A, and that the omitted portions of the frame 102 have beenomitted for clarity.

A constant force in the distal direction, indicated in FIG. 5A by anarrow 351, is maintained on the shaft 303 to keep the sharpened edge 315in contact with the desired connection point 118. The distal force(arrow 351) is seen as a compressive force on the shaft 303.

When the force in the distal direction (indicated by the arrow 351) isholding the sharpened edge 315 in contact with the desired connectionpoint 118, the ultrasonic electric generator 307 and the ultrasonictransducer are activated. The ultrasonic vibration of the ultrasonictransducer 309 is translated to the coupled proximal portion 311 of theshaft 303. The shaft 303 translates the ultrasonic vibration to thedistal portion 313 of the shaft 303, and to the tip assembly 305 coupledthereto. The sharpened edge 315 of the tip assembly 305 focuses themechanical vibration onto the contacted desired connection point 118.The ultrasonic vibration of the sharpened edge 315 against theconnection point 118, combined with the constant force in the distaldirection (indicated by the arrow 351) holding the sharpened edge 315against the connection point 118, fractures or breaks the desiredconnection point 118. Fracturing of the connection point 118 separatesthe adjacent crowns 116 a and 116 b of the valve prosthesis 100 at thefractured connection point 118 such that the adjacent crowns 116 a and116 b are no longer in contact with each other, as shown in FIG. 5B,which shows the fractured connection point 118 with the tip assembly 305of the system 301 omitted for clarity. By focusing the ultrasonicvibration onto a known point, i.e. the desired connection point 118, thesharpened edge 315 breaks or fractures the frame 102 at a known locationand in a known and predictable manner that provides a level of embolicprotection by reducing or eliminating the creation of shards during thefracturing process. Additionally, fracturing the connection point 118with the sharpened edge 315 yields an anatomically safe fracture pointthat reduces the danger of damage to the surrounding tissue.

When the desired connection point 118 has been fractured, the ultrasonicelectric generator 307 and the ultrasonic transducer are deactivated. Ifanother connection point 118 is to be fractured, the process ofmaneuvering the tip assembly 305 to the next desired connection point118 and fracturing of said next desired connection point 118 isrepeated.

In an example shown in FIG. 5C, three (3) connection points 118 havebeen fractured at the inflow end 108 of the frame 102 of the valveprosthesis 100, forming a “zippered down” opening. The fracturing ofthree (3) to four (4) consecutive longitudinally aligned connectionpoints 118 at the inflow end 108 and/or the outflow end 110 of the frame102 will allow radial expansion of the frame 102 to permit avalve-in-valve replacement procedure to be utilized. While fracturing ofthe longitudinally aligned connection points 118 is shown at the inflowend 108, this is by way of example and not limitation. The fracturing ofconnection points 118 may occur at the inflow end 108, the outflow end110, or at any connection point 118 there between. Further, while shownwith a single set of three (3) longitudinally aligned connection points118 being fractured, this too is by way of example and not limitation.It will be understood that the fracturing procedure may be utilized tofracture a single connection point 118, or to fracture more than oneconnection point 118 at any location on the frame 102 in anycombination. The goal of the fracturing procedure is to fracture andseparate enough connection points 118 to permit the frame 102 toradially expand to permit placement and expansion of a new valveprosthesis 100 therein. It will be understood that not every connectionpoint 118 need be fractured to achieve a large diametrical expansion ofthe frame 102 to permit a valve-in-valve replacement.

When fracturing of the desired connection points 118 is complete, thesystem 301 is removed. Fracturing of the desired connection points 118of the frame 102 of the deployed valve prosthesis 100 permits the frame102 to radially expand. Radial expansion of the deployed frame 102 maybe required such that the deployed frame 102 may receive, for example, areplacement valve prosthesis.

FIGS. 6-8 illustrate a system 601 for fracturing a frame of a deployedvalve prosthesis, such as the frame 102 of the valve prosthesis 100previously described herein, with ultrasonic vibration according toanother embodiment hereof. The system 601 includes a shaft 603, a tipassembly 605, an ultrasonic electric generator 607, and an ultrasonictransducer 609. The shaft 603, the ultrasonic electric generator 607,and the ultrasonic transducer 609 are similar to the shaft 303, theultrasonic electric generator 307, and the ultrasonic transducer 309.Therefore, construction and alternatives of the shaft 603, theultrasonic electric generator 605, and the ultrasonic transducer 609will not be repeated. However, in the embodiment of FIGS. 6-8 , thesystem 601 is equipped with an alternative tip assembly 605.

The tip assembly 605 according to an embodiment hereof is shown in FIGS.6-8 . The tip assembly 605 includes a sharpened edge 615, a firstsegment 617, a second segment 619, and a third segment 621. A proximalportion 623 of the tip assembly 605 is coupled to a distal portion 613of the shaft 603. More precisely, the proximal portion 623 of the tipassembly 605 is located on the first segment 617. The tip assembly 605is configured to translate ultrasonic vibration of the tip assembly 605onto the frame 102 of the deployed valve prosthesis 100. The tipassembly 605 may be constructed of materials similar to the tip assembly305 of FIGS. 3-5A. The tip assembly 605 may be coupled to the shaft 603similar to the manner in which the tip assembly 305 is coupled to theshaft 303 of FIGS. 3-5A.

The first segment 617 includes a first longitudinal axis LA1, as shownin FIG. 6 . The second segment 619 of the tip assembly 605 extendsradially outward from, or generally transverse to the first segment 617.The third segment 621 extends proximally from the second segment 619such that the third segment 621 is generally parallel to and radiallyoutward from the first longitudinal axis LA1. Stated another way, thethird segment 621 is generally parallel to and radially spaced apartfrom the first segment 617 and the first longitudinal axis LA1. Thethird segment 621 is configured such that the third segment 621 will notdamage tissue during delivery of the tip assembly 605 to the deployedvalve prosthesis 100 or during fracturing of the frame 102, as describedbelow. Accordingly, in the embodiment of FIGS. 6-8 , the third segment621 includes a conical portion 625 and a rounded or atraumatic tip 627at a proximal portion thereof. While the tip assembly 605, and moreprecisely the first segment 617, the second segment 619, and the thirdsegment 621 have been described herein as a single component, this isnot meant to limit the design and the first segment 617, the secondsegment 619, and the third segment 621 may be separate componentscoupled together by methods such as but not limited adhesives, welding,or other coupling methods as appropriate. Further, while the firstsegment 617, the second segment 619, and the third segment 621 are eachillustrated in FIGS. 6-8 with a generally circular cross-section, thisis by way of example and not limitation. It will be understood thatother cross-sectional shapes may be utilized as previously describedwith respect to the tip assembly 305 of FIGS. 3-5A.

In the embodiment of FIGS. 6-8 , the sharpened edge 615 is formed on aproximal facing surface 631 of the tip assembly 605. The sharpened edge615 is configured to focus or concentrate motion or ultrasonic vibrationof the tip assembly 605 along the first longitudinal axis LA1 of thefirst segment 617 onto the desired connection point 118 of the frame102, to fracture the desired connection point 118, as described below.The sharpened edge 615 may be formed by methods similar to the methodsdescribed for forming the sharpened edge 315 of FIGS. 3-5A.

As shown in FIG. 7 , the tip assembly 605 of the system 601 is advancedto the site of a deployed valve prosthesis 100, in this example at thesite of a native aortic valve AV, and brought into a position adjacentto the connection point 118 to be fractured.

The third segment 621 of the tip assembly 605 is manipulated radiallyoutward through the cell 112 of the frame 102 that is adjacent to aninflow facing surface 130 of the connection point 118 to be fractured.More precisely, the tip assembly 605 is moved radially outward throughthe cell 112 to position the sharpened edge 615 adjacent the inflowfacing surface 130 of the desired connection point 118 to be fractured.

When the sharpened edge 615 is positioned proximal of and adjacent tothe desired connection point 118, the system 601 is proximally retractedto position the sharpened edge 615 of the second segment 619 in contactwith the inflow facing surface 130 of the desired connection point 118,as shown in FIG. 8 , which omits a portion of the frame 102 of the valveprosthesis 100 for clarity.

Next, the shaft 603 is proximally retracted to maintain a constant forcein the proximal direction, indicated in FIG. 8 by the arrow 655, on theshaft 603 and the tip assembly 605. The force in the proximal direction(indicated by the arrow 655) keeps the sharpened edge 615 in contactwith the desired connection point 118. The proximal force (indicated bythe arrow 655) is seen as a tension force by the shaft 603.

When the proximal force (indicated by the arrow 653) is holding thesharpened edge 615 against the proximal facing surface 130 of thedesired connection point 118, the ultrasonic electric generator 607 andthe ultrasonic transducer 609 are activated to fracture the desiredconnection point 118 as previously described with respect to the tipassembly 305 of FIGS. 3-5A.

A system 901 for fracturing a frame of a deployed valve prosthesis, suchas the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to yet another embodimenthereof is shown in FIGS. 9-11 . The system 901 includes a shaft 903, atip assembly 905, an ultrasonic electric generator 907, and anultrasonic transducer 909. The shaft 903, the ultrasonic electricgenerator 907, and the ultrasonic transducer 909 are similar to theshaft 303, the ultrasonic electric generator 307, and the ultrasonictransducer 309 and therefore are not described in detail with respect toFIGS. 9-12 .

The tip assembly 905 according to yet another embodiment hereof is shownin FIGS. 9-11 . The tip assembly 905 includes a sharpened edge 915 and afirst segment 917. The tip assembly 905 is configured to translateultrasonic vibration to the sharpened edge 915 and onto the frame 102 ofthe deployed valve prosthesis 100. Referring to FIG. 9 , the firstsegment 917 includes a proximal portion 923 coupled to a distal portion913 of the shaft 903 as previously described with respect to the tipassembly 305 of FIGS. 3-5A. The sharpened edge 915 is disposed on adistal facing surface 929 of the first segment 917 of the tip assembly905. The sharpened edge 915 is similar to the sharpened edge 315previously described herein.

FIG. 10 shows the tip assembly 905 of the system 901 having beenadvanced to the site of a deployed valve prosthesis 100 and brought intoa position adjacent the desired connection point 118 to be fractured.

The tip assembly 905 is manipulated to place the sharpened edge 915 incontact with the distal facing surface 128 of the connection point 118to be fractured, as shown in FIG. 11 .

The shaft 903 is distally advanced to provide a constant force in thedistal direction, indicated in FIG. 11 by the arrow 951, to keep thesharpened edge 915 in contact with the desired connection point 118.

When the sharpened edge 915 held against the connection point 118 by theconstant force in the distal direction (indicated by the arrow 951), theultrasonic electric generator 907 and the ultrasonic transducer 909 areactivated to fracture the desired connection point 118 as previouslydescribed herein.

FIGS. 12-13 show a system 1201 for fracturing a frame of a deployedvalve prosthesis in accordance with another embodiment hereof. Thesystem 1201 includes a shaft 1203, a tip assembly 1205, an ultrasonicelectric generator 1207, and an ultrasonic transducer 1209. The tipassembly 1205, the ultrasonic electric generator 1207, and theultrasonic transducer 1209 are similar to the tip assembly 305, theultrasonic electric generator 307, and ultrasonic transducer 309previously described herein, except the ultrasonic transducer 1209 isdisposed at a distal portion 1213 of the shaft 1203, as shown in FIG. 12. Therefore similar construction, operation, and alternatives of the tipassembly 1205, the ultrasonic electric generator 1207, and theultrasonic transducer 1209 will not be repeated.

The shaft 1203 of the system 1201 is a generally tubular shape andincludes a proximal portion 1211 and a distal portion 1213. The distalportion 1213 of the shaft 1203 is coupled to the ultrasonic transducer1209 as described below. The shaft 1203 is configured to translateultrasonic vibration generated by the ultrasonic transducer 1239 to thetip assembly 1205, as described below. The tip assembly 1205 is coupledto the distal portion 1213 of the shaft 1203 as previously described forthe shaft 303 and the tip assembly 305 of FIGS. 3-5A. Although describedherein as a single component, it will be understood that the shaft 1203may include multiple components and be formed of similar materials aspreviously described with respect to the shaft 303 of FIGS. 3-5A.

The shaft 1203 further includes a wire lumen 1235 extending from theproximal portion 1211 to the distal portion 1213 of the shaft 1203. Morespecifically, the wire lumen 1235 extends from the proximal portion 1211of the shaft 1203 to the ultrasonic transducer 1209. The wire lumen 1235is configured to retain at least one wire 1237, as best shown in FIG. 13, which is a cross-sectional view of the shaft 1203 taken at line 13-13of FIG. 12 . In the embodiment of FIG. 13 , the shaft 1203 includesthree (3) wires within the wire lumen 1235. In an embodiment, the three(3) wires include a positive, hot, or supply wire, a neutral, negative,or return wire, and a ground, earth, or protection wire. The at leastone wire 1237 extends from the ultrasonic transducer 1209 proximally tothe proximal portion 1211, and may extend to the ultrasonic electricgenerator 1207 such that the ultrasonic electric generator 1207 iselectrically coupled to the ultrasonic transducer 1209. Alternatively, asuitable electrical connection may connect the ultrasonic electricgenerator 1207 with the at least one wire 1237 at the proximal portion1211 of the shaft 1203. Although the wire lumen 1235 is depicted in FIG.13 with a circular cross-section, this is by way of example and notlimitation, and other cross-sectional configurations of the wire lumen1235, including elliptical, oval, crescent shaped, or otherconfigurations suitable for the purposes described herein may beutilized. Further, while shown in FIG. 13 with three (3) wires 1237within the wire lumen 1235, this, too, is by way of example and notlimitation, and more or fewer wires 1237 may be utilized.

The ultrasonic transducer 1209 is coupled to the distal portion 1213 ofthe shaft 1203. The ultrasonic transducer 1209 is configured to receivean electrical signal from the ultrasonic electric generator 1207 via theat least one wire 1237, and convert the electrical signal to ultrasonicvibration or motion. The ultrasonic transducer 1209 is furtherconfigured to translate the ultrasonic vibration to the distal portion1213 of the shaft 1203 to which the ultrasonic transducer 1209 it iscoupled. The ultrasonic transducer 1209 may be coupled to the distalportion 1213 of the shaft 1203 by methods such as, but not limited toadhesives, welding, clamping, or other coupling methods as appropriate.

The interaction of the various components of the system 1201 are similarto the interaction of components of the system 301 previously describedwith respect to FIGS. 3-5A, except that the ultrasonic vibration isgenerated by the ultrasonic transducer 1209 at the distal portion 1213of the shaft 1203.

A system 1401 for fracturing a frame of a deployed valve prosthesis inaccordance with another embodiment hereof is shown in FIG. 14 . Thesystem 1401 includes a shaft 1403, a tip assembly 1405, an ultrasonicelectric generator 1407, and an ultrasonic transducer 1409. The shaft1403, the tip assembly 1405, the ultrasonic electric generator 1407, andthe electronic ultrasonic transducer 1409 are similar to the shaft 1203,the tip assembly 1205, the ultrasonic generator 1207, and the ultrasonictransducer 1209 previously described with FIGS. 12-13 , except in theembodiment of FIG. 14 , the ultrasonic transducer 1209 is disposed atand coupled to a proximal portion 1423 of the tip assembly 1405, asdescribed below. Therefore, similar construction and alternatives willnot be repeated.

The shaft 1403 includes a wire lumen 1435 extending from the proximalportion 1411 to the distal portion 1413 of the shaft 1403. The tipassembly 1405 includes a wire lumen 1439 longitudinally aligned with thewire lumen 1435 of the shaft 1403 such that the wire lumen 1435 and thewire lumen 1439 form a continuous lumen extending from the proximalportion 1411 of the shaft 1403 to the proximal portion 1423 of the tipassembly 1405. The wire lumen 1435 of the shaft 1403 and the wire lumen1439 of the tip assembly 1405 are each configured to retain at least onewire 1437. The at least one wire 1437 extends from the ultrasonictransducer 1409 proximally to the proximal portion 1411, and may extendto the ultrasonic electric generator 1407 to electrically couple theultrasonic transducer 1409 to the ultrasonic electric generator 1407.Alternatively, a suitable electrical connection may connect theultrasonic electric generator 1407 with the at least one wire 1437 atthe proximal portion 1411 of the shaft 1403. The ultrasonic transducer1409 is configured to receive an electrical signal from the ultrasonicelectric generator 1407 via the at least one wire 1437, and convert theelectrical signal to ultrasonic vibration. The ultrasonic transducer1409 is further configured to translate the ultrasonic vibration to thetip assembly 1405. The ultrasonic transducer 1409 may be coupled to theproximal portion 1423 of the tip assembly 1405 by methods such as, butnot limited to adhesives, welding, clamping, or other coupling methodsas appropriate.

The interaction of the various components of the system 1401 are similarto the interaction of components of the system 301 previously describedherein.

A system 1501 for fracturing a frame of a deployed valve prosthesis,such as the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to yet another embodimenthereof is shown in FIGS. 15A-15B. The system 1501 includes a shaft 1503,a tip assembly 1505, an ultrasonic electric generator 1507, and anultrasonic transducer 1509. The tip assembly 1505, the ultrasonicelectric generator 1507, and the ultrasonic transducer 1509 are similarto the tip assembly 305, the ultrasonic electric generator 307, and theultrasonic transducer 309 and therefore are not described in detail withrespect to FIGS. 9-12 .

The shaft 1503 is a flexible catheter shaft with a generally tubularshape. The shaft 1503 includes a proximal portion 1511, a distal portion1513, a proximal end 1541, and a distal end 1543. The shaft 1503 furtherincludes a shaft wall 1545 and a lumen 1547 extending from the proximalend 1541 to the distal end 1543, as shown in FIGS. 15 and 15B. The lumen1547 is sized and configured to receive auxiliary medical devices suchas, but not limited to a guidewire. In the embodiment of FIG. 15 , theproximal portion 1511 is coupled to the ultrasonic transducer 1509 andthe distal portion 1513 is coupled to the tip assembly 1505. The shaft1503 is configured to translate movement or vibration from the proximalportion 1511 to the distal portion 1513. More specifically, the shaft1503 is configured to translate ultrasonic vibration from the ultrasonictransducer 1509 coupled to the proximal portion 1511 to the tip assembly1505 coupled to the distal portion 1513. Although the shaft 1503 isdescribed herein as a single component, this is by way of example andnot limitation, and the shaft 1503 may include components such as, butnot limited to a proximal shaft, a distal shaft, a handle, or othercomponents suitable for the purposes described herein. The shaft 1503may be constructed of materials such as, but not limited to stainlesssteel, titanium, tungsten, tantalum, or other materials suitable for thepurposes of the present disclosure. In an alternative embodiment, theshaft 1503 may be coated or surrounded by a plastic or polymer-basedmaterial such as, but not limited to Polyurethane (e.g. Peliethane©,Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer(e.g. Pebax®, nylon 12), polyethylene, or other materials suitable forthe purposes of the present disclosure.

Although the embodiment of FIGS. 15A-15B is shown with the tip assembly1505 coupled to the wall 1545 of the shaft 1503 at a distal portion 1513thereof, this is by way of example and not limitation. In anotherembodiment, the tip assembly 1505 may be coupled to other locations ofthe distal portion 1513 of the shaft 1503 such as, but not limited to anouter surface of the shaft 1503, an inner surface of the shaft 1503, orany other location suitable for the purposes described herein. Forexample, in another embodiment, the shaft may include a second lumendisposed within the wall of the shaft and configured to receive a secondshaft there through. A tip assembly may be coupled to a distal portionof the second shaft extending distally from the shaft. The second shaftis configured to translate ultrasonic vibration from the shaft to thetip assembly. In an embodiment, the second shaft may be slidably and/orrotatably disposed within the second lumen such that the tip assemblymay be distally advanced, proximally retracted, and/or radially rotatedrelative to the shaft.

The interaction of the various components of the system 1501 are similarto the interaction of components of the system 301 previously describedherein.

FIGS. 16-20 are sectional cutaways views of a heart HE illustrating amethod for fracturing the frame 102 of the deployed heart valveprosthesis 100 using the system 301 of FIGS. 3-5A in accordance with anembodiment hereof. FIG. 16 shows the system 301 having been introducedinto the vasculature via a percutaneous entry point, e.g., the Seldingertechnique, and tracked through the vasculature and into the aorta AO ofthe heart HE with the tip assembly 305 advanced into proximity orapposition with the valve prosthesis 100 at the site of a native aorticvalve AV. Intravascular access to the aortic valve AV may be achievedvia a percutaneous access site to femoral venous access to the aorta AOor other known access routes. A guide catheter GC may be used with thesystem 301 to minimize intravascular trauma during introduction,tracking and positioning of the tip assembly 305 at the desiredlocation. The system 301 has been advanced distally to place the tipassembly 305 adjacent with the cell 112 that is adjacent the outflowfacing surface 128 of the desired connection point 118 of the frame 102that is to be fractured.

In a next step, the system 301, and more precisely the shaft 303 ismanipulated to move the third segment 321 of the tip assembly 305radially outward through the cell 112 that is adjacent the outflowfacing surface 128 of the desired connection point 118 (obscured fromview in FIG. 17 by the tip assembly 305) to be fractured, as shown inFIG. 17 . Movement of the third segment 321 through the cell 112 of theframe 102 positions the sharpened edge 315 (obscured from view in FIG.17 by the tip assembly 305) of the tip assembly 305 adjacent to theconnection point 118 to be fractured.

With reference to FIG. 18 , the shaft 303 of the system 301 is distallyadvanced to place the sharpened edge 315 of the tip assembly 305 incontact with the distal facing surface 128 (in relation to the valveprosthesis 100) of the desired connection point 118 to be fractured.

When the sharpened edge 315 is in contact with the desired connectionpoint 118, the shaft 303 is distally advance to apply a longitudinalforce in the distal direction, indicated by the arrow 351, on the shaft303 and the tip assembly 305 to keep or hold the sharpened edge 315 incontact with the desired connection point 118.

When the sharpened edge 315 is held in contact with the desiredconnection point 118 by the distal force 351, the ultrasonic electricgenerator 307 and the ultrasonic transducer 309 (not visible in FIGS.16-20 ) are activated. The ultrasonic electric generator 307 and theultrasonic transducer 309 remain activated and the longitudinal distalforce 351 is maintained until the desired connection point 118 of theframe 102 fractures or fails, as shown in FIG. 19 .

When the desired connection point 118 has fractured, the ultrasonicelectric generator 307 and the ultrasonic transducer 309 may bedeactivated, and the longitudinal distal force 351 released.

The method steps may be repeated for the next desired connection point118 to be fractured.

As previously described with respect to FIGS. 3-5C, one or more of theconnection points 118 of the frame 102 are fractured at desiredlocations to permit the desired radial expansion of the frame 102 topermit a valve-in-valve replacement. Accordingly, connection points 118may be fractured at and inflow end 108 of the frame 102, at an outflowend 110 of the frame 102, at any other desired location of the frame102, and in any combination.

When all the desired connection points 118 have been fractured, thesystem 301 may be removed. FIG. 20 illustrates the frame 102 of thedeployed heart valve prosthesis 100, wherein three (3) connection points118 in a longitudinal alignment at the inflow end 108 of the frame 102have been fractured, thus permitting a portion of the frame 102 toradially expand and form a “zippered down” opening within an annulus ANof the native aortic valve AV. The system 301 is now removed and thedeployed valve prosthesis 100, or more precisely the frame 102 of thedeployed valve prosthesis 100 is ready to receive a new valve prosthesistherein in a valve-in-valve replacement procedure.

While the method of FIGS. 16-20 is described with the system 301, thisis by way of example and not limitation, and the method may also beutilized with other embodiments of the system including the system 601of FIGS. 6-8 , the system 901 of FIGS. 9-11 , the system 1201 of FIGS.12 and 13 , the system 1401 of FIG. 14 , and the system 1501 of FIGS.15A-15B.

Further, while the method of FIGS. 16-20 is described with the tipassembly 305, this too is by way of example and not limitation, and itwill be understood that a similar method may be employed with thealternated tips assembly configurations including the tip assembly 605of FIGS. 6-8 , the tip assembly 905 of FIGS. 9-11 , the tip assembly1405 of FIG. 14 , and the tip assembly 1505 of FIG. 15A. When utilizedwith the tip assembly 605 of FIGS. 6-8 , the sharpened edge 615 of thetip assembly 605 is placed in contact with a proximal facing surface ofthe connection point 118 to be fractured and the shaft 603 is proximallyretracted to apply the longitudinal force to maintain contact betweenthe sharpened edge 615 and the desired connection point 118.

Although the method has been described with respect to the fracturing ofa frame 102 of a deployed aortic heart valve prosthesis 100, it will beunderstood that the method may be utilized with other prostheses, and atother locations, such as deployed heart valve prostheses at the mitralvalve, the tricuspid valve, or the pulmonary valve.

A system 2101 for fracturing a frame of a deployed valve prosthesis,such as the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to yet another embodimenthereof is shown in FIGS. 21 and 22 . The system 2101 includes a shaft2103 having a proximal portion 2111 and a distal portion 2133, a tipassembly 2105, an ultrasonic electric generator 2107, and an ultrasonictransducer 2109. The ultrasonic electric generator 2107 is electricallycoupled to the ultrasonic transducer 2109 by a connection 2133. Theshaft 2103, the ultrasonic electric generator 2107, the ultrasonictransducer 2109, and the connection 2133 are similar to the shaft 303,the ultrasonic electric generator 307, the ultrasonic transducer 309,and the connection 333, respectively, and therefore are not described indetail with respect to FIGS. 21 and 22 . A proximal portion 2123 of thetip assembly 2105 is coupled to the distal portion 2133 of the shaft2103. The tip assembly 2105 includes a sharpened edge 2115, a firstsegment 2117, a second segment 2119, and a third segment 2121. The tipassembly 2105 is similar to the tip assembly 305 previously describedwith respect to FIGS. 3-5A, except that in the embodiment of FIGS. 21and 22 , the second segment 2119 includes a safety bumper 2161, and thethird segment 2121 includes a flat portion 2125 with a rounded oratraumatic tip 2127 at a distal portion thereof.

In the embodiment of FIGS. 21 and 22 , the flat portion 2125 of thethird segment 2121 of the tip assembly 2105 has a generally flat orplanar shape with an oblong or rectangular cross-section. The flatportion 2125 is configured to be pressed against adjacent tissue tolocate a desired connection 118 to be fractured without damaging theadjacent tissue. Further, the flat portion 2125 is configured to protectagainst deep tissue damage during fracturing of the desired connection118.

In the embodiment of FIGS. 21 and 22 , the safety bumper 2161 isdisposed on a distal facing surface 2129 of the tip assembly 2105. Thesafety bumper 2161 is disposed radially inward relative to a sharpenededge 2115. The safety bumper 2161 is configured to prevent the thirdsegment 2121 from damaging tissue during fracturing of the desiredconnection 118 of the frame 102 of the deployed valve prosthesis 100.More precisely, when the sharpened edge 2115 is disposed against thedesired connection 118, the third segment 2121 is disposed radiallyoutward from the desired connection 118 and the safety bumper 2161 isdisposed radially inward of the desired connection 118. Stated anotherway, the desired connection 118 is sandwiched between the third segment2121 and the safety bumper 2161 as best shown on FIG. 22 .

When the ultrasonic electric generator 2107 and the ultrasonictransducer 2109 are activated, the safety bumper 2161, disposed radiallyinward from and adjacent to the desired connection 118 prevents the tipassembly 2105 from moving radially outward, thereby further preventingthe third segment 2121 from moving radially outward and damagingadjacent arterial tissue. A constant force in the distal direction,indicated in FIG. 22 by an arrow 2151, is maintained on the shaft 2103to keep the sharpened edge 2115 in contact with the desired connectionpoint 118.

FIGS. 23 and 24 show a system 2301 for fracturing a frame of a deployedvalve prosthesis, such as the frame 102 of the valve prosthesis 100previously described herein, with ultrasonic vibration according to yetanother embodiment hereof. The system 2301 includes a shaft 2303 havinga proximal portion 2311 and a distal portion 2313, a tip assembly 2305,an ultrasonic electric generator 2307, and an ultrasonic transducer2309. The ultrasonic electric generator 2307 is electrically coupled tothe ultrasonic transducer 2309 by a connection 2333. The shaft 2303, theultrasonic electric generator 2307, the ultrasonic transducer 2309, andthe connection 2333 are similar to the shaft 303, the ultrasonicelectric generator 307, the ultrasonic transducer 309, and theconnection 333, respectively, and therefore are not described in detailwith respect to FIGS. 23 and 24 . A proximal portion 2323 of the tipassembly 2305 is coupled to the distal portion 2313 of the shaft 2303.The tip assembly 2305 includes a sharpened edge 2315, a first segment2517, a second segment 2519, and a third segment 2321. The tip assembly2305 is similar to the tip assembly 2105 previously described withrespect to FIGS. 21 and 22 , except that in the embodiment of FIGS. 23and 24 a third segment 2321 includes a flat portion 2325 with a squaretip 2327 at a distal portion thereof.

In the embodiment of FIGS. 23 and 24 , the flat portion 2325 of thethird segment 2321 of the tip assembly 2305 has a rectangular shape witha rectangular or oblong cross-section. The flat portion 2325 isconfigured to be pressed against adjacent tissue to locate a desiredconnection 118 to be fractured without damaging the adjacent tissue.Further, the flat portion 2325 is configured to protect against deeptissue damage during fracturing of the desired crown 118. The tip 2327has a square shape, flat, or blunt distal end.

In the embodiment of FIGS. 23 and 24 , a safety bumper 2361 is similarto the safety bumper 2161 of the embodiment of FIGS. 21 and 22 .Therefore, the safety bumper 2361 is not described in detail withrespect to FIGS. 23 and 24 . When the ultrasonic electric generator 2307and the ultrasonic transducer 2309 are activated, the safety bumper2361, disposed radially inward from and adjacent to the desiredconnection 118 prevents the tip assembly 2305 from moving radiallyoutward, thereby further preventing the third segment 2321 from movingradially outward and damaging adjacent arterial tissue. A constant forcein the distal direction, indicated in FIG. 24 by an arrow 2351, ismaintained on the shaft 2303 to keep the sharpened edge 2315 in contactwith the desired connection point 118.

A system 2501 for fracturing a frame of a deployed valve prosthesis,such as the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to yet another embodimenthereof is shown in FIGS. 25-29 . The system 2501 includes a shaft 2503,a tip assembly 2505, an ultrasonic electric generator 2507, and anultrasonic transducer 2509. The ultrasonic electric generator 2507, andthe ultrasonic transducer 2509 are similar to the ultrasonic electricgenerator 307 and the ultrasonic transducer 309 and therefore are notdescribed in detail with respect to FIGS. 25-29 . In the embodiment ofFIGS. 25-29 , the tip assembly 2505 includes a collapsed configurationfor delivery and an expanded configuration for ultrasonic fracturing ofthe frame 102 of the valve prosthesis 100. The shaft 2503 is configuredto permit transition of the tip assembly 2505 from the collapsedconfiguration of FIGS. 25 and 26 to the expanded configuration of FIG.28 in situ, with the tensioning of a pull wire 2571, as described below.

The shaft 2503 is similar to the shaft 303 previously described withrespect to FIGS. 3-5A, except that the shaft 2503 further includes apull wire lumen 2535. The pull wire lumen 2535 extends the full lengthof the shaft 2503 to the tip assembly 2505. The pull wire lumen 2535 issized to slidably receive the pull wire 2571 therein, as best shown inFIG. 27 , which is a cross-sectional view of the shaft 2503 taken atline 27-27 of FIG. 25 . In the embodiment of FIGS. 25-29 , the shaft2503 includes one (1) pull wire 2571 within the pull wire lumen 2535.Although the pull wire lumen 2535 is depicted in FIG. 26 with a circularcross-section, this is by way of example and not limitation, and othercross-sectional configurations of the pull wire lumen 2535, includingelliptical, oval, or other configurations suitable for the purposesdescribed herein may be utilized.

The pull wire 2571 is configured to transition the tip assembly 2505from the collapsed configuration of FIGS. 25 and 26 to the expandedconfiguration of FIG. 28 when the pull wire is placed in tension, asdescribed below. The pull wire 2571 includes a proximal end 2573extending proximally from the shaft 2503. The pull wire extends distallyfrom the proximal end 2573, through the pull wire lumen 2535 to a distalend 2575. The distal end 2575 of the pull wire 2571 is coupled to athird segment 2521 of the tip assembly 2505 as described below. In anembodiment, the pull wire 2571 is an elongate member formed of materialssuch as, but not limited to stainless steel or any other materialsuitable for the purposes described herein. In an embodiment, the pullwire 2571 may including a coating thereon to enhance slidability.

The tip assembly 2505 is configured to translate ultrasonic vibration ofthe tip assembly 2505 onto the frame 102 of the deployed valveprosthesis 100 to fracture the frame 102 of the deployed valveprosthesis 100, as previously described with respect to the tip assembly305 of FIGS. 3-5C. Further, the tip assembly 2505 is configured totransition between the collapsed configuration and the expandedconfiguration. The tip assembly 2505 includes a sharpened edge 2515, afirst segment 2517, a second segment 2519, and the third segment 2521.The first segment 2517, the second segment 2519, and the third segment2521 are each individual components pivotably coupled to one another toprovide articulation to transition the tip assembly 2505 from thecollapsed configuration to the expanded configuration in situ, asdescribed below.

In the embodiment of FIGS. 25-29 , the first segment 2517 and the secondsegment 2519 each have a generally wishbone or “Y” shape. The thirdsegment 2521 has a generally linear shape with a generally rectangularcross-section. The tip assembly 2505 may be constructed of materialssuch as, but not limited to stainless steel or other materials suitablefor the purposes of the present disclosure. The tip assembly 2505 may becoupled to the shaft 2503, for example, and not by way of limitation byadhesives, welding, clamping, or other coupling methods as appropriate.While the tip assembly 2505 is shown coupled to the shaft 2503 in aparticular coupling configuration, this is by way of example and notlimitation, and it will be understood that other coupling configurationsmay be utilized. Further, while the first, second, and third segments2517, 2519, and 2521 of the tip assembly 2505 have each been describedwith a specific shape, this is by way of example and not limitation, andthe first, second, and third segments 2517, 2519, and 2521 may each haveany number of alternative shapes to permit the tip assembly 2505 totransition between the collapsed and the expanded configurations.

More particularly, the first segment 2517 includes a generally wishboneor “Y” shape as best shown in FIG. 26 , which is a top view illustrationof the tip assembly 2505 in the collapsed configuration. As best shownin FIG. 29 , which is an exploded view illustration of the tip assembly2505 in the expanded configuration, the first segment 2517 furtherincludes a first aperture 2577 and a first stop 2579 at a distal portionthereof. The first segment 2517 includes a first longitudinal axis LA1(shown on FIG. 28 ). The second segment 2519 of the tip assembly 2505includes a generally wishbone or “Y” shape. The second segment 2519further includes a first aperture 2581 at a radially inward portionthereof, and a second aperture 2583 and a second stop 2585 at a radiallyoutward portion thereof. The third segment 2521 includes a firstaperture 2587 disposed at a distal portion thereof, and a coupling point2599 disposed proximal of the first aperture 2587. In the embodiment ofFIGS. 25-29 , the first aperture 2581 of the second segment 2519 isco-located with the first aperture 2577 of the first segment 2517 and afirst pivot pin 2589 is disposed through the co-located first apertures2577 and 2581 to pivotably couple the second segment 2519 to the firstsegment 2517. The second segment 2519 is configured to pivot about thepivot pin 2589 between the collapsed configuration of FIG. 25 and theexpanded configuration of FIG. 28 . Similarly, the first aperture 2587of the third segment 2521 is co-located with the second aperture 2583 ofthe second segment 2519 and a second pivot pin 2591 is disposed throughthe co-located apertures 2587 and 2583 to pivotably couple the thirdsegment 2521 to the second segment 2519.

When the tip assembly 2505 is in the collapsed configuration, as bestshown in FIG. 27 , the second segment 2519 is pivotably disposed withina wishbone portion of the first segment 2517, and the third segment 2521is pivotably disposed within a wishbone portion of the second segment2519. The first, second, and third segments 2517, 2519, and 2521 arenested within one another and aligned generally parallel to the firstlongitudinal axis LA1.

When the tip assembly 2505 is in the expanded configuration, as shown inFIG. 28 , the second segment 2519 of the tip assembly 2505 extendsradially outward from, or generally transverse to the first segment2517, and the third segment 2521 extends distally from the secondsegment 2519 such that the third segment 2521 is generally parallel toand radially outward from the first longitudinal axis LA1.

In the embodiment of FIGS. 25-29 , the first pivot pin 2589 and thesecond pivot pin 2591 are each biased such that the tip assembly 2505 isconfigured to return to the collapsed configuration of FIG. 25 when atrest. Accordingly, the first pivot pin 2589 is pivotably disposed withinthe first aperture 2577 of the first segment 2517 and disposed withinand coupled to the first aperture 2581 of the second segment 2519 suchthat the second segment 2519 returns to the collapsed configuration ofFIG. 25 when the pull wire 2571 is not in tension. Further, the secondpivot pin 2591 is pivotably disposed within the second aperture 2583 ofthe second segment 2519 and is disposed within and coupled to the firstaperture 2587 of the third segment 2521 such that the third segment 2521returns to the collapsed configuration of FIG. 25 when the pull wire2571 is not in tension. Biasing of the first and second pivot pins 2589,2591 may be accomplished by springs or other biasing mechanisms as willbe understood by persons knowledgeable in the pertinent art.

The first stop 2579 is configured to prevent the second segment 2519from pivoting beyond a position generally curved traverse to the firstsegment 2517 when the tip assembly 2505 is in the expandedconfiguration. More precisely, when the tip assembly 2505 is in theexpanded configuration, a radially inward end 2593 of the second segment2519 contacts the first stop 2579 of the first segment 2517, when thesecond segment 2519 is generally transverse to the first segment 2517.Further, when the tip assembly 2505 is in the expanded configuration, adistal end 2595 of the third segment 2521 contacts the second stop 2585of the second segment 2519 when the third segment 2521 is generallyparallel to the first segment 2517. Stated another way, the first andsecond stops 2579 and 2585 each prevent the second and third segments2519, 2521, respectively, from pivoting beyond or to a greater degreethan the expanded configuration of FIG. 28 .

In the embodiment of FIGS. 25-29 , as best shown in FIG. 29 , thesharpened edge 2515 is disposed on a radially inward facing surface 2597of the third segment 2521 of the tip assembly 2505. The sharpened edge2515 is similar to the sharpened edge 615 previously described withrespect to FIGS. 6-8 , except that the sharpened edge 2015 is disposedon a different surface of the tip assembly 2505. The sharpened edge 2515is configured to focus or concentrate ultrasonic vibration or motion ofthe tip assembly 2505 to fracture a desired connection point of a frameof a deployed valve prosthesis as previously described.

Assembly of the articulating tip assembly 2505 will now be describedwith reference to FIGS. 28 and 29 . The first aperture 2577 of the firstsegment 2517 is co-located with the first aperture 2581 of the secondsegment 2519. The first pivot pin 2589 is disposed through the firstapertures 2577, 2581 to pivotably couple the second segment 2519 to thefirst segment 2517. The second aperture 2583 of the second segment 2519is co-located with the first aperture 2595 of the third segment 2521.The second pivot pin 2591 is disposed through the co-located first andsecond apertures 2595, 2583 of the third segment to 2521 and the secondsegment 2519, respectively, to pivotably couple the third segment 2521to the second segment 2519. The distal end 2575 of the pull wire 2571 iscoupled to the third segment 2521 at the coupling point 2599, as bestshown in FIG. 30 . The distal end 2575 of the pull wire or 2521 may becoupled to the third segment 2521 by methods such as but not limited toadhesives, fusing, welding, tying, or any other method suitable for thepurposes described herein. The pull wire 2571 extends distally from thecoupling point 2599 of the third segment 2521 around a distal portion ofthe second pivot pin 2591. The pull wire 2571 then extends radiallyinward and around a distal portion of the first pivot pin 2589. Finally,the pull wire 2571 extends proximally within the pull wire lumen 2535 ofthe shaft 2503. The proximal end 2573 of the pull wire extendsproximally from the shaft 303 such that the pull wire 2571 may bemanipulated or placed into tension to transition the tip assembly 2505from the collapsed configuration to the expanded configuration.

With reference to FIGS. 25-29 , the interaction of the variouscomponents of the system 2501 will now be described to articulate, move,or transition the tip assembly 2505 from the collapsed configuration tothe expanded configuration. When the system 2501 is in the collapsedconfiguration of FIG. 25 with the second segment 2519 nested within aportion of the first segment 2517, and the third segment 2521 nestedwithin a portion of the second segment 2519, the pull wire 2571 ispulled in a proximal direction to place the pull wire 2571 into tension.Tension on the pull wire 2571 is translated to tension or pull at thedistal end 2575 of the pull wire and translated to the connection point2599 of the third segment 2521 coupled thereto. Accordingly, as the pullwire 2571 is placed into tension, the third segment 2521 and thepivotably coupled second segment 2519 of the tip assembly 2505 eachpivot about their respective pivot pins 2591, 2589 to transition the tipassembly 2505 from the collapsed configuration of FIG. 25 to theexpanded configuration of FIG. 28 . More precisely, as the tip assembly2505 transitions from the collapsed configuration to the expandedconfiguration, the second segment 2519 pivots about the first pivot pin2589 in a radially outward direction, from a position generally parallelto and aligned with the first longitudinal axis LA1 to a positiongenerally transverse to the first segment 2517. Pivoting of the secondsegment 2519 is stopped when the inward end 2593 of the second segment2519 contacts the first stop 2579 of the first segment 2517. Further, asthe tip assembly 2505 transitions from the collapsed configuration tothe expanded configuration, the third segment 2521 pivots about thesecond pivot pin 2591 in a radially outward direction from a positiongenerally parallel to and aligned with the first longitudinal axis LA1to a position generally parallel to and radially outward from the firstlongitudinal axis LA1. Pivoting of the third segment 2521 is stoppedwhen the distal end 2595 of the third segment 2521 contacts the secondstop 2581 of the second segment 2519.

When tension on the pull wire 2571 is released, the biasing of the firstand second pivot pins 2589 and 2591 permit the tip assembly 2505 totransition from the expanded configuration of FIG. 28 to the collapsedconfiguration of FIG. 25 .

While the system 2501 of FIGS. 25-29 has been described with a specificconfiguration, this is by way of example and not limitation. Forexample, in another embodiment, the tip assembly 2505 may be biased tothe expanded configuration. In yet another embodiment, the tip assembly2505 can be formed from a shape memory material and be restrained anddelivered to the desired site in the collapsed configuration whereinonce positioned, the restraint may be removed and the tip assembly 2505permitted to self-expand. “Self-expand” as used herein means that thetip assembly 2505 has a mechanical memory to return to the expandedconfiguration. The salient factor herein is that the tip assembly 2505includes the collapsed configuration for delivery and the expandedconfiguration for ultrasonically fracturing a frame of a deployed valveprosthesis. Accordingly, the tip assembly 2505 may include anyconfiguration suitable to transition the tip assembly 2505 from thecollapsed delivery configuration to the expanded configuration.

A system 3001 for fracturing a frame of a deployed valve prosthesis,such as the frame 102 of the valve prosthesis 100 previously describedherein, with ultrasonic vibration according to yet another embodimenthereof is shown in FIGS. 30A-32 . The system 3001 includes a first shaft3003, a second shaft 3050, a first tip assembly 3005, a second tipassembly 3052, an ultrasonic electric generator 3007, and an ultrasonictransducer 3009. The first shaft 3003, ultrasonic electric generator3007, and the ultrasonic transducer 3009 are similar to the shaft 1503,the ultrasonic electric generator 1507, and the ultrasonic transducer1509 and therefore are not described in detail with respect to FIGS.30A-32 .

In the embodiment of FIGS. 30A-32 , as best shown in FIG. 31 , the firsttip assembly 3005 includes a sharpened edge 3015, a first segment 3017,a second segment 3019, and a third segment 3021. The first tip assembly3005 is similar to the tip assembly 1505 of FIGS. 15A-16 , except that athird segment 3021 of the first tip assembly 3005 extends proximallyfrom a second segment 3019 of the first tip assembly 3005. Therefore,similar construction and alternatives will not be repeated. It will beunderstood that in the embodiment of FIGS. 30A-32 the first tip assembly3005 includes the sharpened edge 3015 disposed on a distal facingsurface 3029 of the second segment 3019, which is a close up perspectiveview of the first and second tip assemblies 3005, 3052, respectively.While the embodiment of FIGS. 30A-32 illustrates the tip assembly 3005with a flat third segment 3021 and a square tip 3027 similar to the flatthird segment 2321 of FIGS. 23 and 24 , this is by way of example andnot limitation. It will be understood that the third segment 3021 mayhave other configurations including but not limited to the flat roundedconfiguration of FIGS. 21 and 22 , or any other suitable configuration.

The second shaft 3050 is a flexible catheter shaft with a shaft wall3045 having a generally tubular shape. The second shaft 3050 isconfigured to be slidably and rotatably disposed within a lumen 3047 ofthe first shaft 3003, as best viewed in the cross-section illustrationof FIG. 30B. The second shaft 3050 includes a proximal portion 3054 anda distal portion 3056. In the embodiment of FIGS. 30A-32 , the secondshaft 3050 is configured to translate movement from the proximal portion3054 to the distal portion 3056. More specifically, the second shaft3050 is configured to translate movement from the proximal portion 3054to the second tip assembly 3052 coupled to the distal portion 3056.Although the second shaft 3050 is described herein as a singlecomponent, this is by way of example and not limitation, and the secondshaft 3050 may include components such as, but not limited to a proximalshaft, a distal shaft, a handle, or other components suitable for thepurposes described herein. The second shaft 3050 may be constructed ofmaterials such as, but not limited to stainless steel, titanium,tungsten, tantalum, or other materials suitable for the purposes of thepresent disclosure.

The second shaft 3050 is configured to be disposed with a portionthereof extending outside of a patient, i.e., the proximal portion 3054,and a portion thereof positioned in situ within a body lumen or vessel,i.e., the distal portion 3056. The second shaft 3050 is furtherconfigured to deliver and position the second tip assembly 3052 of thesystem 3001 at the site of the deployed valve prosthesis 100, asdescribed below. Accordingly, the second shaft 3050 and the second tipassembly 3052 are each sized and configured to be advanced through avasculature in a minimally invasive manner.

As best viewed in FIG. 31 , the second tip assembly 3052 includes afirst segment 3058, a second segment 3060, and a third segment 3062. Aproximal portion 3064 of the second tip assembly 3052 is coupled to thedistal portion 3056 of the second shaft 3050. The second tip assembly3052 is configured to hold or stabilize a distal portion of the frame102 of the deployed valve prosthesis 100 as the first tip assembly 3005fractures the frame 102 of the deployed valve prosthesis 100. In theembodiment of FIGS. 30A-32 , the first segment 3058 and the secondsegment 3060 of the tip assembly 305 each include a generally tubularshape with a generally circular cross-section. The third segment 3062includes a generally flat or planar shape with a generally rectangularcross-section. The second tip assembly 3052 may be constructed ofmaterials such as, but not limited to stainless steel, nickel-titaniumalloys (i.e. NITINOL), or other materials suitable for the purposes ofthe present disclosure. The second tip assembly 3052 may be coupled tothe second shaft 3050, by methods such as, but not limited to adhesives,welding, clamping, or other coupling methods as appropriate. While thesecond tip assembly 3052 is shown coupled to the second shaft 3050 in aparticular coupling configuration, this is by way of example and notlimitation, and it will be understood that other coupling configurationsmay be utilized. For example, and not by way of limitation, a proximalend of the second tip assembly 3052 may be coupled to a distal end ofthe second shaft 3050. Further, while the first and second segments 3058and 3060 of the tip assembly 305 have each been described with agenerally tubular shape and a generally circular cross-section, this isby way of example and not limitation. The first and second segments 3058and 3060 may each have alternative shapes including, but not limited toshapes with an oblong cross-section, a rectangular cross-section, or anyother suitable shape. Even, further, while the third segment 3062 hasbeen described with a generally flat, rectangular shape with a generallyrectangular cross-section, this is again by way of example and notlimitation. The third segment 3062 may have alternative shapesincluding, but not limited to rounded, oblong, or conical shapes and acircular or oblong cross-section, or any other suitable shape.

The first segment 3058 includes a second longitudinal axis LA2, as bestshown in FIG. 30A. The second segment 3060 of the second tip assembly3052 extends radially outward from, or generally transverse to the firstsegment 3058. The third segment 3062 extends distally from the secondsegment 3060 such that the third segment 3062 is generally parallel toand radially outward from the second longitudinal axis LA2. In theembodiment of FIGS. 30A-32 , the third segment 3062 includes a flatportion 3066 and a square tip 3068 at a distal portion thereof. Thethird segment 3062 is configured such that the third segment 3062 willnot damage tissue during delivery of the second tip assembly 3052 to thedeployed valve prosthesis 100 or during fracturing of the frame 102.While the second tip assembly 3052, and more precisely the first segment3058, the second segment 3060, and the third segment 3062 have beendescribed herein as a single component, this is not meant to limit thedesign and the first segment 3058, the second segment 3060, and thethird segment 3062 may be separate components coupled together bymethods such as but not limited adhesives, welding, or other couplingmethods as appropriate

The interaction of the various components of the system 3001 will now bedescribed to fracture a connection point, such as the connection point118 of the frame 102 of the deployed valve prosthesis 100 with referenceto FIG. 32 . With the components of the system 3001 assembled andconfigured as described above, the system 3001 is advanced to the siteof the deployed valve prosthesis 100. The first tip assembly 3005 ismanipulated to place the sharpened edge 3015 in contact with an inflowfacing surface 130 of the connection point 118 to be fractured, as shownin FIG. 32 and as previously described with respect to the first tipassembly 305 of FIGS. 4 and 5A-5C.

The third segment 3062 of the tip assembly 3052 is brought intoapposition with the desired connection point 118 to be fractured. Thesecond tip assembly 3052 is manipulated to position the second segment3060 in contact with the connection point 118 to be fractured on theopposite side of the connection point 118 to the first tip assembly3005. In the embodiment of FIG. 32 , this includes manipulating thesecond tip assembly 3052 radially outward such that the third segment3062 passes through one cell 112 of the frame 102 that is adjacent to anoutflow facing surface 128 of the desired connection point 118 to befractured.

When the second segments 3019, 3060 of the first and second tipassemblies, 3005, 3052, respectively, are each positioned on oppositesides of the connection with the desired connection point 118 sandwichedthere between, the first shaft 3003 is distally advanced to place thesharpened edge 3015 in contact with the inflow facing surface 130 of theconnection point 118 to be fractured, and the second shaft 3050 isproximally retracted to place the second shaft 3019 in contact with theoutflow facing surface 128 of the connection point 118 to be fractured,as best shown in FIG. 32 . It will be understood that only a portion ofthe frame 102 is illustrated in FIG. 32 , and that the omitted portionsof the frame 102 have been omitted for clarity.

A first constant force in the distal direction, indicated in FIG. 32 byan arrow 3068, is maintained on the first shaft 3003 to keep thesharpened edge 3015 in contact with the desired connection point 118 anda second constant force in the proximal direction, indicated in FIG. 32by an arrow 3070, is meant maintained on the second shaft 3050 to keepthe second segment 3019 in contact with the desired connection point118.

When the first constant force in the distal direction (indicated by thearrow 3068) is holding the sharpened edge 3015 in contact with thedesired connection point 118 and the second constant force in theproximal direction (indicated by the arrow 3070) is holding the secondsegment 3019 in contact with the desired connection point 118, theultrasonic electric generator 3007 and the ultrasonic transducer 3009are activated. The ultrasonic vibration of the ultrasonic transducer3009 is translated to a coupled proximal portion 3011 (shown in FIG.30A) of the first shaft 3003. The shaft 3003 translates the ultrasonicvibration to a distal portion 3013 of the first shaft 3003, and to thefirst tip assembly 3005 coupled thereto. The sharpened edge 3015 of thefirst tip assembly 3005 focuses the mechanical vibration onto thecontacted desired connection point 118. The second constant force in theproximal direction (indicated by the arrow 3070) holds the secondsegment 3019 of the second shaft 3050 in contact with the desiredconnection point 118 to stabilize the connection point 118 duringfracturing. Stabilizing of the connection point 118 during ultrasonicfracturing provides additional force to keep the sharpened edge 3015 ofthe first tip assembly 3005 in contact with the connection point 118,thereby preventing the system 3001 from moving relative to the frame 102and damaging the surrounding tissue during fracturing.

When the desired connection point 118 has been fractured, the ultrasonicelectric generator 3007 and the ultrasonic transducer 3009 aredeactivated. If another connection point 118 is to be fractured, theprocess of maneuvering the first and the second tip assemblies 3005 and3052, respectively, to the next desired connection point 118 andfracturing of said next desired connection point 118 is repeated.

While described herein with the sharpened edge 3015 disposed on thefirst tip assembly 3005, this is by way of example and not limitation.For example, in another embodiment hereof, the sharpened edge 3015 isdisposed on a distal facing surface of the second segment 3060 of thesecond tip assembly 3052 and the second shaft 3050 is configured totranslate ultrasonic vibrations from the ultrasonic electric generator3007 and the ultrasonic transducer 3009 to the second tip assembly 3052.In yet another embodiment hereof, the second segment 3019 of the firsttip assembly 3005 and the second segment 3060 of the second tip assembly3052 each include a sharpened edge 3015, and both the first shaft 3003and the second shaft 3050 are each configured to translate ultrasonicvibrations to the respective first and second tip assemblies 3005, 3052to fracture the desired connection point 118.

As described above, by focusing the ultrasonic vibration onto a knownpoint, i.e. the desired connection point, tip assemblies according toembodiments hereof break or fracture a frame of a deployed prosthesis ata known location and in a known and predictable manner that provides alevel of embolic protection by reducing or eliminating the creation ofshards during the fracturing process. However, in addition, embolicprotection devices may be utilized with any embodiment hereof. Moreparticularly, embolic protection devices are known to one of ordinaryskill in the art to deal with debris or fragments that are dislodged inthe circulatory system during treatment procedures. One protectiontechnique includes the temporary placement of an intravascular filter ortrap downstream from the treatment site to capture debris before it canreach and embolize smaller blood vessels downstream. The placement of afilter in the patient's vasculature during treatment can collect embolicdebris in the bloodstream. At the end of the treatment procedure, thefilter can be removed along with the captured debris. Such filterstypically comprise a filtration membrane, mesh or “basket” having aplurality of pores, each pore being sized to prevent passage ofparticulate larger than a certain size, e.g., 100-200 microns.Conventionally, embolic filters are positioned downstream from thetreatment device such that the filter may be deployed in a location thatdoes not interfere or interact with the treatment device. For example,it is known to attach an expandable filter to a guidewire orguidewire-like member that allows the filtering device to be placed inthe patient's vasculature. The guidewire allows the physician to steerthe filter to a location downstream from the area of treatment. Once theguidewire is in proper position in the vasculature, the embolic filtercan be deployed to capture embolic debris. Treatment devices then can bedelivered to the area of treatment by tracking over the guidewire orguidewire-like member.

In addition, image guidance, enhanced echogenicity, or other methods maybe used to aid the clinician's delivery and positioning of any systemdescribed herein. Image guidance, e.g., intracardiac echocardiography(ICE), fluoroscopy, computed tomography (CT), intravascular ultrasound(IVUS), optical coherence tomography (OCT), or another suitable guidancemodality, or combination thereof, may be used to aid the clinician'spositioning and manipulation of the systems described herein at thetarget site of a deployed valve prosthesis. For example, such imageguidance technologies can be used to aid in determining the positioningof the tip assemblies described herein with relation to the deployedvalve prosthesis and the target region thereof that is to be fracturedby the tip assembly. In some embodiments, image guidance components(e.g., IVUS, OCT) can be coupled to the distal portion of the shaft, thetip assembly, or both to provide three-dimensional images of the areaproximate to the target deployed valve prosthesis to facilitatepositioning, orienting and/or deployment of the systems described hereinwithin the target site of a deployed valve prosthesis. Accordingly, anechogenic coating may be applied to components of the system to aid invisualization.

While only some embodiments according to the present invention have beendescribed herein, it should be understood that they have been presentedby way of illustration and example only, and not limitation. Variouschanges in form and detail can be made therein without departing fromthe spirit and scope of the invention. Further, each feature of eachembodiment discussed herein, and of each reference cited herein, can beused in combination with the features of any other embodiment. Allpatents and publications discussed herein are incorporated by referenceherein in their entirety.

What is claimed is:
 1. A system for fracturing a frame of a prosthesiscomprising: a shaft having a proximal portion and a distal portion; atip assembly coupled to the distal portion of the shaft, the tipassembly including: a first segment extending along a longitudinal axis;a second segment extending from a distal end of the first segment andtransverse to the first segment, the second segment including a cuttingedge; and a third segment extending distally from a second end of thesecond segment opposite a first end of second segment coupled to thefirst segment, the third segment extending transverse to the secondsegment such that the third segment is generally parallel to thelongitudinal axis; an ultrasonic electric generator; and an ultrasonictransducer electrically coupled to the ultrasonic generator andconfigured to generate ultrasonic vibration, wherein the ultrasonicvibration generated by the ultrasonic transducer is translated to thetip assembly.
 2. The system of claim 1, wherein the ultrasonictransducer is coupled to the proximal portion of the shaft, and whereinthe shaft is configured to translate the ultrasonic vibration generatedby the ultrasonic transducer to the tip assembly.
 3. The system of claim1, wherein the ultrasonic transducer is coupled to the distal portion ofthe shaft, and wherein the shaft is configured to translate theultrasonic vibration generated by the ultrasonic transducer to the tipassembly.
 4. The system of claim 1, wherein the ultrasonic transducer iscoupled to the first segment of the tip assembly.
 5. The system of claim1, wherein the cutting edge is disposed on a distal facing surface ofthe second segment.
 6. The system of claim 1, wherein the shaft includesa lumen extending through the proximal portion and the distal portion,and wherein the tip assembly is coupled to a wall of the shaft at thedistal portion such that a medical device is enabled to extend throughthe lumen and distal of the tip assembly.
 7. A system for fracturing aframe of a prosthesis comprising: a first shaft having a proximalportion, a distal portion and a lumen extending through the proximalportion and the distal portion; a first tip assembly coupled to thefirst shaft, wherein the first tip assembly includes a first segmenthaving a first end coupled to the first shaft, the first segmentextending transverse the first shaft; a second shaft slidably disposedwithin the lumen of the first shaft, the second shaft having a proximalportion and a distal portion; a second tip assembly coupled to thedistal portion of the second shaft, the second tip assembly including afirst segment having a first end coupled to the second shaft, the firstsegment extending transverse to the second shaft; a first cutting edgedisposed on a distal facing surface of the first segment of the firsttip assembly and a second cutting edge disposed on a proximal facingsurface of the first segment of the second tip assembly; an ultrasonicelectric generator; and an ultrasonic transducer electrically coupled tothe ultrasonic generator, wherein ultrasonic vibration generated by theultrasonic transducer is translated to the first tip assembly and/or thesecond tip assembly, wherein the second shaft is slidable within thefirst shaft such that the second tip assembly is longitudinally slidablerelative to the first tip assembly.
 8. A system for fracturing a frameof a prosthesis comprising: a shaft having a proximal portion and adistal portion; a tip assembly coupled to the distal portion of theshaft, the tip assembly including: a first segment extending along alongitudinal axis; a second segment extending from a distal end of thefirst segment and transverse to the first segment, the second segmentincluding a cutting edge; and a third segment extending from a secondend of the second segment opposite a first end of second segment coupledto the first segment, the third segment extending transverse to thesecond segment such that the third segment is generally parallel to thelongitudinal axis, wherein the tip assembly includes a collapsedconfiguration for delivery and an expanded configuration for fracturingthe frame of the deployed prosthesis, wherein in the collapsedconfiguration, the first segment, the second segment, and the thirdsegment are generally parallel to a central longitudinal axis of theshaft; an ultrasonic electric generator; and an ultrasonic transducerelectrically coupled to the ultrasonic generator and configured togenerate ultrasonic vibration, wherein the ultrasonic vibrationgenerated by the ultrasonic transducer is translated to the tipassembly.
 9. The system of claim 8, further comprising a pull wireconfigured to transition the tip assembly from the collapsedconfiguration to the expanded configuration.
 10. A tip assembly forfracturing a frame of a deployed prosthesis with ultrasonic vibrationcomprising: a first segment extending along a longitudinal axis; asecond segment extending from a distal end of the first segment andtransverse to the first segment; a third segment extending from a secondend of the second segment opposite a first end of second segment coupledto the first segment, the third segment extending distally from thesecond segment and transverse to the second segment such that the thirdsegment is generally parallel to the longitudinal axis; and a cuttingedge disposed on a surface of the second segment.
 11. The tip assemblyof claim 10, wherein the cutting edge is disposed on a distal facingsurface of the second segment.
 12. The tip assembly of claim 10, whereinthe tip assembly includes a collapsed configuration for delivery and anexpanded configuration for fracturing the frame of the deployedprosthesis, wherein in the collapsed configuration, the first segment,the second segment, and the third segment are generally parallel to thelongitudinal axis.
 13. A system for fracturing a frame of a prosthesiscomprising: a shaft having a proximal portion and a distal portion; atip assembly coupled to the distal portion of the shaft, the tipassembly including: a first segment extending along a longitudinal axis;a second segment extending from a distal end of the first segment andtransverse to the first segment, the second segment including a cuttingedge; a third segment extending from a second end of the second segmentopposite a first end of second segment coupled to the first segment, thethird segment extending transverse to the second segment such that thethird segment is generally parallel to the longitudinal axis; and abumper extending from the second segment, wherein the cutting edge isdisposed between the bumper and the third segment, the bumper extendingfrom the second segment parallel to the third segment; an ultrasonicelectric generator; and an ultrasonic transducer electrically coupled tothe ultrasonic generator and configured to generate ultrasonicvibration, wherein the ultrasonic vibration generated by the ultrasonictransducer is translated to the tip assembly.
 14. The system of claim13, wherein the cutting edge is disposed on a distal facing surface ofthe second segment and the third segment extends distally from thesecond segment.
 15. A system for fracturing a frame of a prosthesiscomprising: a first shaft having a proximal portion, a distal portionand a lumen extending through the proximal portion and the distalportion; a first tip assembly coupled to the first shaft, wherein thefirst tip assembly includes a first segment having a first end coupledto the first shaft, the first segment extending transverse the firstshaft, and a second segment extending from a second end of the firstsegment and transverse the first segment such that the second segment isgenerally parallel to the first shaft; a second shaft slidably disposedwithin the lumen of the first shaft, the second shaft having a proximalportion and a distal portion; a second tip assembly coupled to thedistal portion of the second shaft, the second tip assembly including afirst segment having a first end coupled to the second shaft, the firstsegment extending transverse to the second shaft; a cutting edgedisposed on the first segment of the first tip assembly and/or the firstsegment of the second tip assembly; an ultrasonic electric generator;and an ultrasonic transducer electrically coupled to the ultrasonicgenerator, wherein ultrasonic vibration generated by the ultrasonictransducer is translated to the first tip assembly and/or the second tipassembly, wherein the second shaft is slidable within the first shaftsuch that the second tip assembly is longitudinally slidable relative tothe first tip assembly.
 16. The system of claim 15, wherein the secondtip assembly further includes a second segment extending from a secondend of the first segment and transverse the first segment such that thesecond segment is generally parallel to the second shaft.